Researchers Urge Greater Awareness of Delayed Skin Reactions to Moderna COVID-19 Vaccine

Researchers at Massachusetts General Hospital (MGH) are calling for greater awareness and communication regarding a delayed injection site reaction that can occur in some patients who have received the Moderna mRNA-1273 vaccine.

In a letter to the editor published online in the New England Journal of Medicine (NEJM), the researchers noted phase 3 clinical data from the Moderna vaccine trial did show delayed skin hypersensitivity in a small number of the more than 30,000 trial participants. However, the authors mention that large, red, sometimes raised, itchy, or painful skin reactions were never fully characterized or explained. They warn that clinicians may not be prepared to recognize them and guide patients on treatment options and completion of the second dose of the vaccine.

"Whether you've experienced a rash at the injection site right away or this delayed skin reaction, neither condition should prevent you from getting the second dose of the vaccine," said lead study author and co-director of the Clinical Epidemiology Program in the division of Rheumatology, Allergy and Immunology at MGH Kimberly Blumenthal, MD, MSc, in a press release. "Our immediate goal is to make physicians and other care providers aware of this possible delayed reaction, so they are not alarmed, but instead well-informed and equipped to advise their patients accordingly."

In the letter, Blumenthal and her co-authors noted their clinical observations of the delayed, large, local reactions to the Moderna vaccine, and report on a series of 12 patients with the reactions. In that group, symptom onset ranged from 4 days after the first dose up to 11 days post-vaccination, with a median onset of symptoms on day 8. Photographs show the varied size and severity of the reactions, and most patients were treated with ice and antihistamines, although some required corticosteroids and 1 was erroneously treated with antibiotics.

"Delayed cutaneous hypersensitivity could be confused- by clinicians and patients alike-with a skin infection," said letter co-author Erica Shenoy, MD, PhD, associate chief of the MGH Infection Control Unit, in a press release. "These types of reactions, however, are not infectious and thus should not be treated with antibiotics."

Symptoms cleared up after approximately 1 week for the group of 12 reported in the letter. Half of the patients went on to experience a reaction after the second dose, at or approximately 48 hours post-vaccination, whereas no patients experienced a second dose reaction that was more severe than their first dose reaction, according to the study authors.

The study authors also mention that samples taken from skin biopsies confirmed their suspicion of a delayed allergic immune response that is commonly seen in drug reactions.

"For most people who are experiencing this, we believe it's tied to the body's immune system going to work," said Esther Freeman, MD, PhD, director of Global Health Dermatology at MGH and co-author of the NEJM letter, in a press release. "Overall, this data is reassuring and should not discourage people from getting the vaccine."

REFERENCE

Researchers urge greater awareness of delayed skin reactions to Moderna COVID-19 vaccine. EurekAlert! https://www.eurekalert.org/pub_releases/2021-03/mgh-rug030321.php. Published March 3, 2021. Accessed March 8, 2021.